Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-17 and 28, in the reply filed on 7/14/2026 is acknowledged.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “first anchor” and the “second anchor” of claim 10 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 6 is objected to because of the following informalities: in line 1, “the movable member” should read “the movable emitter member” for consistency. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 14 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 14 recites “the central region”. Because claim 13 includes a plurality of flexible beams each including a central region, it is unclear which central region of the plurality of previously recited central regions is being referenced in claim 14. As best understood, it appears that “the central region” is meant to refer to the central region each of the plurality of flexible beams. For purposes of claim interpretation, claim 14 is being considered to read “the central region of each of the plurality of flexible beams”
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 5-8, 10, 13, and 16 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Kat-kuoy (US 2018/0153568). Kat-kuoy discloses a catheter for treating an occlusion in a body lumen, the catheter comprising: an outer elongate member (120; []0035] and figs. 3-4) including a fluid lumen; a flexible enclosure (balloon 105) secured to a distal region of the outer elongate member (see figs. 3a; [0035]), the flexible enclosure being fillable with a conductive fluid (140) via the fluid lumen; an inner elongate member (104), positioned within the outer elongate member and extending through the flexible enclosure to a distal region of the flexible enclosure; and a movable emitter member (106) having an emitter assembly (110) mounted thereon and connected to a power source (via 129; [0030]), the movable emitter member located between the inner elongate member and the outer elongate member (see figs. 3a-c) and movable in a longitudinal direction (via 124; [0036]) between the inner elongate member and the outer elongate member.
Regrading claim 2, in a first configuration of the movable emitter member, the emitter assembly is at a first location, and, in a second configuration of the movable emitter member, the emitter assembly is at a second location more distal of the first location ([0035]).
Regrading claim 3, the emitter assembly is located proximal of the flexible enclosure in the first configuration, and the emitter assembly is located within the flexible enclosure in the second configuration ([0035]).
Regrading claim 5, further comprising a proximal hub (116; fig. 7), wherein the outer elongate member (120), the inner elongate member (104), and the movable emitter member (106) extend to the proximal hub and translation of the movable emitter member along the inner elongate member at the proximal hub (via 124) moves the emitter assembly.
Regrading claim 6, translation of the movable member by a distance d at the proximal hub moves the emitter assembly by the distance d in the longitudinal direction (noting emitter assembly 110 is mounted on movable emitter member 106).
Regrading claim 7, the proximal hub comprises a distal end opening fluidically sealed to a proximal end of the outer elongate member (as understood by inflation fluid passing from inflation port 130 into proximal end of outer elongate member; fig. 4).
Regrading claim 8, the inner elongate member includes indicia (114a,114b) that correlate to the longitudinal position of the emitter assembly within the flexible enclosure.
Regrading claim 10, the proximal hub comprises a position stabilizer (slot 127) with a first anchor (125) at a first location of the proximal hub and a second anchor (end of slot opposite 125, which is unnumbered but also limits movement of handle 124) at a second location of the proximal hub (fig. 5), more proximal of the first location, and the movable emitter member includes a proximal end (best shown in fig. 4) translatable between the first anchor and the second anchor. The ends of the slot are considered anchors as they each anchor the handle against further movement in one direction.
Regrading claim 13, the emitter assembly (now considered 110, 132,134,136; fig. 6) comprises an emitter centering member (see fig. 6) including: a proximal band (136); a distal band (134); and a plurality of flexible beams (each of wires 132; see [0038] – one or more wires 132) connecting the proximal band to the distal band, each beam having a central region that extends radially outward (as compared to either end of the beams connected directly to bands 134 or 136).
Regrading claim 16, the emitter centering member comprises one or more of a polymer and a metal (flexible beams 132 are copper wires; [0038]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kat-kuoy Kat-kuoy discloses the invention substantially except for that the inner elongate member has an outer diameter d1 and the movable emitter member includes a lumen having a diameter d2 that is at least 0.002 inch greater than d1. It would have been obvious to size the movable emitter member of Kat-kuoy, that is received over the inner elongate member, such that its lumen has a diameter d2 that is at least 0.002 inch greater than the outer diameter d1 of the inner elongate member since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984, cert. denied, 468 U.S. 830, 225,SPQ 232 (1984). In the instant case, the prior art of Kat-kuoy would not perform differently with the claimed dimensions since the movable emitter member of Kat-kuoy is able to slide over the inner elongate member to move the location of the emitter assembly relative to the balloon.
Claim(s) 4, 17 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kat-kuoy in view of Grace (US 2016/0184570). Regarding claims 4 and 28, Kat-kuoy discloses the invention substantially as stated above in more detail (see discussion of claim 1 above) including an elongate member (120) including a fluid lumen, a flexible enclosure (balloon 105) and a movable emitter (106) having an emitter assembly (both 110) thereon that comprises a plurality of emitters. Kat-kuoy fails to expressly disclose that a distance from a proximal most emitter to a distal most emitter is less than or equal to l/2 (i.e., less than or equal to 0.5l), wherein l is the working length of the balloon.
Grace discloses another catheter for treating an occlusion in a body lumen, the catheter including a movable emitter member. Grace discloses that the working length of the balloon may be 20 cm and further discloses that the space between the two emitters may be 6.7mm apart ([0129]). Thus, it would have been obvious to have modified the prior art of Kat-kuoy to provide the balloon with a length of 20mm and a spacing between the two emitters of 6.7mm, such that the distance between the emitters is less than or equal to half the working length, in view of Grace’s teaching that such dimensions for a balloon and shockwave emitter spacing are known in the art as satisfactory for producing shockwaves within a balloon for treatment of a lesion and thus the results of such a modification would have been predictable and one skilled in the art would have had a reasonable expectation of success.
Regarding claim 17, Kat-kuoy is silent on the length of the balloon. Grace teaches a length of 60mm is appropriate for a balloon used to treat occlusions within a body lumen ([0129]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Kat-kuoy to size the balloon to be 60 mm, which meets the limitation “at least 50 mm”, since Kat-kuoy is silent on the length of the balloon and Grace teaches that such sizing of balloons used to treat occlusions is known in the art, and thus one skilled in the art would have looked to the prior art of Grace to determine a suitable size for the balloon with a reasonable expectation of success.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kat-kuoy in view of Lenker et al. (US 2010/0114017) and Leedle et al. (US 2008/0009784). Kat-kuoy discloses the invention substantially as stated above except for the proximal hub comprising a distal diaphragm seal and a proximal diaphragm seal as claimed.
Lenker disclose another balloon catheter that includes a proximal hub (3600; fig. 36a) including a proximal diaphragm seal (hemostasis seal 3622, which may be a pinhole valve which is considered to read on “diaphragm”) at the proximal-most end of the handle (fig. 36a) and a distal seal (either one of 3612), wherein the distal seal allows a movable tubular portion (3610) and its sliding handle (3618) to be moved while maintaining a seal with the hub regardless of the location of the movable tubular portion in the hub ([0261]). It would have been obvious to have modified the prior art of hub of Kat-kuoy to include a proximal diaphragm seal at the proximal end of the hub as taught by Lanker for the predictable result of preventing blood or other body fluids from leaking out the proximal end of the hub while the inner elongate member extends therefrom as is known in the art (note that the inner elongate member103 exits the proximal end of the hub of Kat-kuoy as shown in fig. 4). It would also have been obvious to include a distal seal as taught by Lenker that surrounds the movable emitter member (106; fig. 4 of Kat-kuoy) in order to maintain a fluid seal between the hub and the movable emitter member independent of the axial location of the movable emitter member as taught by Lenker. Noting that the inner elongate member (103) passes through the movable emitter member (106) in the prior art of Kat-kuoy, the inner elongate member will also pass through this distal seal of Kat-kuoy as modified by Lenker. Lenker does not expressly disclose that the distal seal is a diaphragm seal and instead discloses an o-ring type seal. However, Leedle discloses that a rolling diaphragm is a known alternative to an o-ring when forming a fluid tight seal between a movable inner member and the inner surface of an outer member that receives the movable inner member ([0053]; fig. 5, 16-18). It would have been obvious to one of ordinary skill in the art to have further modified the prior art of Kat-kuoy in view of Lenker to replace the o-ring distal seal with a diaphragm distal seal since the two types of seals are known alternatives as taught by Leedle and such a modification is considered a substitution of one known type of seal for another wherein the results are predictable and one skilled in the art would have had a reasonable expectation of success.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kat-kuoy in view of Anderson (US 4,706,670). Kat-kuoy discloses the invention substantially as stated above except for at least one of the inner elongate member and the movable emitter member comprising polytetrafluoroethylene (“PTFE”).
Anderson discloses another balloon catheter including an inner elongate member (26) positioned within an outer elongate member (4) and extending through a balloon (8) to a distal region of the balloon (see fig. 4a-c). Anderson discloses that the inner elongate member comprises PTFE (col. 5, ll. 26-33). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Kat-kuoy to construct the inner elongate member of PTFE in view of Anderson’s teaching of the suitability of PTFE for the construction of an inner elongate member of a balloon catheter and it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice (In re Leshin, 125 USPQ 416).
Allowable Subject Matter
Claim 15 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 14 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, in a manner consistent with the suggestion set forth above in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN SONNETT HOLWERDA whose telephone number is (571)272-5576. The examiner can normally be reached M-F, 8-5, with alternate Fridays off.
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KSH 7/31/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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